HOT TEMP CAUTERY— 510(k) K771189

Clearance details

Applicant

Edward Weck, Inc.

Product code

Code HQP

Device class

Class 2

Regulation

21 CFR 886.4115

Advisory panel

Ophthalmic

Date received

1977-07-01

Decision date

1977-07-11

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Mchenry, IL, US

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• Z-3045-2018 — Beaver Accu-Temp High Temperature Cautery, 2 inch Shaft with Fine Tip, Model Number 8445000 Product Usage: The indications and intended use of the High Temp cautery are for coagulating tissue or arresting bleeding from small vessels by heat conducted through the wire tip. Indications include ophthalmic, general and plastic surgery.Class II·Terminated·Beaver Visitec·20180719

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K771189.